Buccal drug delivery

摘要

A lozenge is provided that has stable pH and stable levels of active ingredient over time. It comprises a combination of (i) at least one gum and (ii) at least one non-crystallizing sugar or non-crystallizing sugar alcohol in a matrix designed for controlled buccal delivery of a drug. The lozenge also contains water and optional components selected from flavorings, taste masking agents, colorings, buffer components, pH adjusting agents, excipients, stabilizers and sweeteners. Methods of preparing the lozenge are also provided.

主权项

1. A method of making a glassy lozenge comprising a non-crystalline matrix having a hydrogel structure, an active agent and water for buccal drug delivery comprising the steps:
a) mixing a gum, one or more non-crystallising sugars or non-crystallising sugar alcohols and water; b) heating the mixture with mixing; c) adding an active agent and mixing; and d) moulding the mixture to form lozenges;wherein the matrix comprises (i) at least one gum and (ii) at least one non-crystallising sugar or non-crystallising sugar alcohol; wherein the matrix comprises, by weight, from 40-90% of gum component (i), and from 60-10% of the non-crystallising sugar or non-crystallising sugar alcohol component (ii); wherein the lozenge dissolves or disintegrates gradually;wherein the active agent is selected from an anti-emetic agent, an agent for migraine treatment, and an analgesic agent; and wherein step (b) comprises heating the mixture to at least 90° C.